510(k) K981562 ยท EBF Material, Tooth Shade, Resin
SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT
| Applicant | Sulzer Calcitek, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jul 30, 1998 |
| Received | May 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981562
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.